Los Angeles Prospective GI Biliary and EUS Series
Endoscopic retrograde cholangiopancreatography and endoscopic ultrasound are increasingly being used to manage complex disease of the bile duct, pancreas and cancer. Gastroenterology patients at the Los Angeles County Hospital presents a unique and diverse patient population.
Our aim is to study the biochemical, radiographic, and clinical predictors of bile duct stones. Exploratory aims include the study of the management of cholangitis, bile leaks, GI cancer diagnosis and management, and the management of pancreaticobiliary problems in the underserved.
All patients managed by EUS or ERCP at the LA County & USC University Hospitals will be enrolled in the databaseThe timing, clinical presentation, and objective details of patient presentation are recorded prospectively. Additionally the results of the subsequent ERCP and EUS procedures. Subsequent, clinical course and pathology will also be recorded.
Other: clinical course
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Prospective Evaluation of Pancreatic, Biliary, and Gastrointestinal Neoplasia by Endoscopic Retrograde Cholangiopancreatography (ERCP) and Endoscopic Ultrasound (EUS)|
- Successful ERCP or EUS [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]Completed ERCP or EUS in which objectives of procedure were met.Unsuccessful ERCP will be classified as secondary to technical (such as failed cannulation or stent placement) versus sedation failure in which patient could not be sedated.
- Bile Duct Stone [ Time Frame: 1 year ] [ Designated as safety issue: No ]Definite bile duct stone confirmed by cholangiogram
- Length of Hospitalization [ Time Frame: 1 year ] [ Designated as safety issue: No ]Duration of hospitalization from presentation to the emergency department to discharge or death.
- Definitive Diagnosis [ Time Frame: 1 year ] [ Designated as safety issue: No ]Pathologic diagnosis which enables definitive treatment plan, answer
|Study Start Date:||September 2010|
|Estimated Study Completion Date:||December 2018|
|Estimated Primary Completion Date:||December 2018 (Final data collection date for primary outcome measure)|
All patients who undergo ERCP and EUS for clinical indications will undergo a detailed prospective assessment of clinical course.
Other: clinical course
Detailed presentation including labs, demographics, imaging of those who undergo ERCP/EUS with be prospectively recorded. Details of procedure including sedation strategy and success will be collected. Results of procedure including final pathology results with be recorded.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT02196935
|Contact: James Buxbaum, MDfirstname.lastname@example.org|
|Contact: Maria Trujilloemail@example.com|
|United States, California|
|Los Angeles County Hospital||Recruiting|
|Los Angeles, California, United States, 91030|
|Contact: Maria Trujillo 323-409-6939 firstname.lastname@example.org|
|Principal Investigator: James Buxbaum, MD|
|Principal Investigator:||James L Buxbaum, MD||University of Southern California School of Medicine|